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Details for New Drug Application (NDA): 018081

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NDA 018081 describes DEPAKENE, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. Additional details are available on the DEPAKENE profile page.

The generic ingredient in DEPAKENE is valproic acid. There are seventeen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the valproic acid profile page.

Summary for NDA: 018081

valproic acid
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 018081

Suppliers and Packaging for NDA: 018081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
valproic acid
CAPSULE;ORAL 018081 NDA AbbVie Inc. 0074-5681 0074-5681-13 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-5681-13)
valproic acid
CAPSULE;ORAL 018081 NDA REMEDYREPACK INC. 61786-855 61786-855-02 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (61786-855-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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